We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:

Root cause analysis
Investigation experience for QN/CAPAclosures
Experience with manual and automated systems/lines

Requirements

Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
Strong experience in the Medical Device industry (required).
Pharmaceutical industry experience (preferred).
Demonstrated experience with validation life cycle activities (design, execute, analyze, and close protocols/reports).
Experience performing root cause analysis and implementing solutions.
Experience supporting investigations, QN, and CAPA closures.
Experience working with manual and automated manufacturing systems/production lines.
Ability to work effectively in a fast-paced manufacturing environment.
Standard site schedule; flexible to support 24/7 operation including shifts, weekends, and holidays as operational demands requireBilingual (English and Spanish) required.
Availability to work in Texas.

Erforderliche Kompetenzen

Validation lifecycle (design, write, execute, analyze, close protocols/reports)Root cause analysisInvestigations and CAPA management (QN/CAPA closures)Working with manual manufacturing systems/production linesWorking with automated manufacturing systems/production linesMedical device industry experience and regulatory awarenessPharmaceutical industry knowledge (preferred)Protocol and technical report writingImplementing corrective and preventive actionsProcess troubleshooting and problem solving in manufacturingAbility to operate effectively in a fast-paced, 24/7 manufacturing environment (shift flexibility)Bilingual communication (English and Spanish)

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